As the Director, Regulatory Medical Writing, you will be responsible for overseeing, authoring, and editing of clinical documents (e.g., CSR, protocols, IBs), regulatory agency briefing documents and response documents, periodic safety reports, as well as marketing applications (BLA, NDA, MAA, NDS), and investigational applications (IND, CTA) for our development programs providing regulatory compliant documents with consistent messaging and use of program-specific technical terms resulting in well written, reader-friendly documents and applications.
Good things are happening at Omeros!
Come join our Omeros Regulatory Affairs Team!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
Primary author, working cross-functionally, to prepare regulatory documents, including but not limited to, research reports, agency briefing documents, agency response documents, Module 2 overview and summary documents that will be submitted to regulatory authorities such as the FDA, European Medicines Agency and Health Canada
Working closely with clinical and other cross-functional content owners, to prepare high-quality key documents such as Investigator’s Brochures, clinical protocols, technical reports, and other scientific documents that may be submitted to regulatory agencies
Coordinating all writing resources, QC, and formatting for major documents (e.g., regulatory submissions, complex clinical study reports)
Ensuring that Omeros writing standards are met
Preparation of regulatory documents for all types of submissions in electronic Common Technical Document (eCTD) format
Assisting in the development and maintenance of templates and guidelines for the standardization of documents
Assisting in the maintenance of the Omeros Style Guide and providing training to Omeros employees
Assisting with the management of cross-functional review of documents and reconciling comments with the primary author
Managing document preparation in accordance with established timelines, including writing, editing, QC, cross-functional review, eCTD readiness for pre-publishing, and final hand-off to document management
Providing writing support for ad hoc projects that may include preparation of abstracts, posters, or other materials for physicians and Medical Affairs
Education, Experience, Skills, and Knowledge Required:
Bachelor’s degree and a minimum of 8 years as a technical/regulatory writer in the biopharmaceutical industry
Experience preparing regulatory documents for all types of submissions in electronic Common Technical Document (eCTD) format
A solid understanding of FDA/ICH guidelines and GCPs; familiarity with GLPs and GMPs desired
Excellent technical/regulatory writing skills and strong verbal communication skills
Display strong analytical and problem-solving skills, superior attention to detail
Expert abilities in Microsoft Office Professional, Adobe Acrobat, and experience with scientific graphing applications
Adept at version control, formatting, and managing large electronic documents
Behavioral Competencies Required:
Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
Demonstrated ability to work in a team environment
Physical Demands Required:
Intermittent physical activity including bending, reaching, pushing, pulling or lifting up to 10 lbs.
May encounter prolonged periods of sitting
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to firstname.lastname@example.org contact Omeros, asking for Human Resources, at (206) 676-5000.
True innovation requires the right people, and that’s what we have at Omeros – smart, hard-working and creative individuals who collaborate and drive to achieve what has not yet been done. We see strength in diversity – diversity in thought, expertise and experience.
We have taken a similar approach in structuring our company. While many biotechs pursue a single therapeutic area or scientific platform, we are strategically building a deep and diverse pipeline of first-in-class small-molecule and antibody therapeutics. The strength of our scientific discoveries and exclusive intellectual property positions enable our pipeline programs to target highly promising receptors and enzymes that others have not been able to develop.
Although cutting across a wide and diverse range of disorders and therapeutic indications – some orphan, others large-market and many for which there are no approved treatments – all of our drugs on the market and in development target critical unmet needs to improve the lives of patients in meaningful ways.